EP1210136B1 - Device for the administration of an injectable product - Google Patents

Device for the administration of an injectable product Download PDF

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Publication number
EP1210136B1
EP1210136B1 EP00941864A EP00941864A EP1210136B1 EP 1210136 B1 EP1210136 B1 EP 1210136B1 EP 00941864 A EP00941864 A EP 00941864A EP 00941864 A EP00941864 A EP 00941864A EP 1210136 B1 EP1210136 B1 EP 1210136B1
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EP
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Prior art keywords
fluid
drive
piston
space
set forth
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EP00941864A
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German (de)
French (fr)
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EP1210136A1 (en
Inventor
Peter Michel
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Tecpharma Licensing AG
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Disetronic Licensing AG
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/1454—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons spring-actuated, e.g. by a clockwork
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M2005/14513—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons with secondary fluid driving or regulating the infusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/14566—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir for receiving a piston rod of the pump

Definitions

  • the invention relates to a device for administering an injectable product.
  • Injection devices for example hypodermic syringes or injection pens, of which the invention is particularly but not exclusively concerned, usually comprise a housing in which an ampoule containing the product to be injected, a delivery means for conveying the product from the ampoule, a drive means and a coupling device are received are.
  • the conveying means is usually formed by a piston displaceable in the ampoule.
  • the driving force used in simple syringes is the muscle power of the user.
  • spring elements in particular of compression springs, as a drive means.
  • the coupling device forms a transmission path or drive connection from the drive means to the conveying means.
  • the known drive means for example drive springs
  • the drive energy changes according to the spring characteristic.
  • the delivery rate of the conveyor follows such changes. Accordingly, in the course of a discharge of the product, the Aus sectionrate changes according to the changing drive power.
  • US 5,788,673 discloses a fluid infusion system comprising a pumping device and a syringe.
  • a drive piston drives a driven piston via a fluid.
  • a throttle inhibits the fluid to enter a chamber from which the fluid is displaced with the drive piston other chamber to run.
  • the chambers are arranged axially behind one another, in another embodiment next to one another.
  • the object of the invention is to provide a device for administering an injectable product, with which the product is evenly distributed in the course of an injection or infusion.
  • the invention is based on a device for administering an injectable product comprising a housing, a container for the product accommodated by the housing, a conveying means, a drive means and a transmission line or coupling device. With the funding directly the product is conveyed out of the container.
  • the drive means supplies the drive energy required for this, which is transmitted in the transmission path to the conveyor, such that the conveyor is driven to dispense the product from the drive means.
  • the container, the conveying means, the drive means and the transmission members of the transmission path are arranged in the housing.
  • the injectable product is preferably a medicinal or cosmetic active ingredient, in particular in the form of a liquid active substance solution.
  • a prominent example is insulin administered with the device as part of diabetes therapy.
  • the device is preferably an infusion device. It can also be an injection device.
  • the container may in particular be designed as an ampoule, as is the case with known infusion devices.
  • the conveying means is preferably formed by a piston accommodated in the container, which is advanced towards the discharge of product to an outlet of the container. However, instead of such a piston, the conveying means may basically be formed by any type of pump suitable for conveying the product.
  • the drive means is preferably designed in such a way that it releases a self-stored energy when it is triggered. By a coupling device, this energy released in the transmission path to the Transfer funds transmitted in turn so powered the product from the container.
  • the drive means is preferably formed by a drive spring, more preferably it is a compression spring. In principle, however, other types of drive means can be used, for. For example, those that release a pressurized gas in their release.
  • a fluid space for an incompressible fluid and a pressure reducing device in the transmission path from the drive means to the conveyor, i. provided in the coupling device, a fluid space for an incompressible fluid and a pressure reducing device.
  • the fluid space accordingly has a drive side to which the drive means acts and an output side which acts on the conveyance. Both the drive side and the output side can be connected directly or only via further transmission elements to the drive means or the conveyor.
  • the fluid space can be acted upon by pressure on the drive side of the drive means.
  • the pressure thus generated is reduced from the pressure reducing means to the output side of the fluid space.
  • the pressure is reduced to one fifth or less, and more preferably one tenth or less, by means of the pressure reducing means.
  • the invention enables the use of a drive means in which a much larger energy is stored than would be required to drive the conveyor and the associated distribution of the product.
  • the relatively large drive energy released when the drive means is released is reduced to the level required for distribution and administration by the fluid coupling according to the invention.
  • the excess of drive energy is controlled because of the fluid coupling according to the invention for the drive of the conveyor available.
  • a drive spring is used as drive means, as is preferred, then the spring strength of this drive means can be considerably greater than in the case of a direct drive connection with the conveyor.
  • such a Drive spring can be operated in a smaller range of their spring characteristic than would be possible in the case of a direct coupling.
  • a working stroke of the drive means is transferred by the fluid coupling in a working stroke of the conveying means, which is greater than the working stroke of the drive means.
  • a compression or tension spring as a drive means and a piston as a conveyor of each working stroke is the elongation or compression of the spring and the distance traveled by the piston as a function of this stroke.
  • the conveyor is designed as a piston and the drive means also acts on a piston, which is referred to below as the drive piston.
  • the drive side of the fluid space is formed in this embodiment by a piston surface of the drive piston.
  • the piston area of the drive piston is preferably larger than a piston area of an output piston, with the piston area of the output piston forming the output side of the fluid space.
  • the output piston can form the conveyor directly.
  • the output piston is a different piston.
  • the fluid space is subdivided into a first subspace comprising the drive side and a second subspace comprising the drive side.
  • the first subspace or the second subspace is formed as an annular chamber between an outer sleeve and an inner sleeve and the other of the two subspaces in the inner sleeve.
  • the two subspaces are interconnected exclusively by a capillary system, if there is a higher pressure on the drive side than on the output side of the fluid space.
  • the capillary system can be formed by a single or by a plurality of capillaries.
  • the capillary or the plurality of capillaries is or are advantageously as long as possible. Preferably, their length is at least 0.5 m. If several capillaries are formed, this preferably applies to each of the capillaries.
  • the flow rate of long capillaries is less dependent on the diameter of the capillary, as is readily apparent from Hagen-Poiseuille's law. According to the law of Hagen-Poiseuille, variations in diameter due to manufacturing inaccuracies in the fourth power in the flow rate. However, as the capillary length increases, its diameter can also be increased if the flow rate is to remain constant. Larger diameters are on the one hand easier to produce from home than smaller diameters, and with increasing size of the diameter deviations from the nominal diameter increasingly less to book. Furthermore, the highest possible viscosity of the working fluid in the fluid space is preferred.
  • the capillary system preferably has a spirally extending capillary or several such capillaries.
  • the capillary system is formed by a single, spiral capillary.
  • a spiral capillary not only brings the advantage of a long length, but can also be easily manufactured. It can be formed in particular in the form of an external or internal thread on a corresponding lateral surface of a capillary body.
  • the capillary body with the external or internal thread is preferably inserted in or on another body with a smooth mantle surface, care being taken to that the threads of the capillary body are sealed against each other on the mantle surface.
  • FIG. 1 shows a longitudinal section of an infusion device.
  • a circular cylindrical outer sleeve 3 forms, together with a closure piece 9 at a proximal end and a closure cap 19 at a distal end, a housing of the infusion device.
  • a container holder 4a is kept centered in a proximal portion of the outer sleeve 3.
  • a container 1 in the form of an ampoule is also centered to the central longitudinal axis of the outer sleeve 3 added.
  • the container 1 is filled with a product to be injected, for example insulin.
  • a conveyor 2 in the form of a delivery piston is further received in a straight line to an outlet of the container 1 to be displaced.
  • a catheter 20 is connected in a conventional manner.
  • an inner sleeve 4b is arranged concentrically with the outer sleeve 3.
  • the container holder 4a and the inner sleeve 4b are formed as a one-piece sleeve.
  • the container holder 4a and the inner sleeve 4b could also be separate components. Due to the one-piece design, however, the common, centered mounting in the outer sleeve 3 is simplified, as can be seen from FIG. 1 and the following description.
  • An inner circumferential surface of the inner sleeve 4b forms a sliding guide for a driven piston 6 accommodated in the inner sleeve 4b, which is rigidly connected to the delivery piston 2 by means of a piston rod 7.
  • the output piston 6 and the piston rod 7 are integrally formed.
  • the piston rod 7 abuts the delivery piston 2. You could also be firmly connected to the delivery piston; For example, it could be bolted to the delivery piston 2. Further, the piston rod 7 may also be slidably guided in a neck region between the container holder 4a and the inner sleeve 4b, for example, guided in a fluid-tight manner.
  • the output piston 6 seals with sealing rings 17 in the manner of piston rings to the inner sleeve 4b down.
  • the drive piston 5 is an annular piston which is fluid-tightly and tightly slid in the annular space between the outer sleeve 3 and the inner sleeve 4b.
  • the drive piston 5 has a flat annular surface on a distal end face. In the proximal direction, the drive piston 5 tapers toward the inner sleeve 4b.
  • the rejuvenation is formed by means of a shoulder. The shoulder is in the proximal direction opposite to a counter surface of the infusion device.
  • the mating surface is formed by a spacer in the form of a spacer 9a, which surrounds the container holder 4a and rests loosely on the closure piece 9.
  • a compression spring 8 is added abutting both surfaces between the two opposing surfaces, namely the shoulder of the drive piston 5 and the spacer ring 9a.
  • a capillary body 10 is arranged in the distal direction behind the drive piston 5.
  • the capillary body 10 has a proximal annular region and terminates at its distal end with a bottom.
  • the capillary body 10 seals against the outer sleeve 3 and preferably also against the inner Sleeve 4b fluid-tight.
  • a distal end face of the inner sleeve 4b presses against the bottom of the capillary body 10 in a fluid-tight manner via a sealing ring 18.
  • the capillary body 10 is provided with a passage opening 14.
  • a passage open in only one direction is formed by a check valve.
  • the check valve has a valve ball 11, which is pressed in a known manner by means of a valve spring 12 into its seat within the capillary body 10.
  • the valve spring 12 in turn is supported on a valve closure 13.
  • a fluid space sealed by these two pistons 5 and 6 is formed with a first subspace 21 and a second subspace 22.
  • the two subspaces 21 and 22 are separated from each other by the capillary body 10.
  • the fluid space 21, 22 is completely filled with an incompressible working fluid.
  • a high-viscosity oil is preferably used as the working fluid.
  • the check valve 11, 12, 13 allows a flow of the working fluid only from the subspace 22 in the subspace 21 and prevents flow in the other direction.
  • the capillary body 10 forms a fluid connection in the form of a capillary system with a surrounding inner circumferential surface of the outer sleeve 3.
  • the capillary system is shown in detail I of Figure 2. It is formed by a single continuous fluid channel, namely a capillary 23.
  • the capillary 23 runs in the form of a multi-thread thread spirally around the outer surface of the capillary body 10.
  • the capillary 23 can in principle also be formed by a single thread. It connects in the installed state of the capillary body 10, the two fluid subspaces 21 and 22.
  • the capillary 23 opposite inner lateral surface of the outer sleeve 3 is simply smooth. The capillary body 10 is pushed into the outer sleeve 3 under slight pressure.
  • the teeth of the capillary body 10 are flattened for sealing purposes.
  • the capillary body 10 is made of a softer material than the outer sleeve 3 to improve the seal. In principle, however, the outer sleeve 3 could be made of a softer material than the capillary body 10 for the same purpose.
  • FIG. 3 shows an alternative embodiment of a capillary 23.
  • the capillary 23 is formed in this case in an insert as a straight fluid channel.
  • the insert is kept fluid-tight in a receptacle of the capillary body.
  • the capillary 23 of the insert extending bore is formed, so that in this embodiment by means of a capillary 23, a fluid connection between the two sub-spaces 21 and 22 is created.
  • a spacer ring 9a By inserting a spacer ring 9a, a simple compensation of all occurring in the transmission path from the compression spring 8 to the output piston 6 deviations from corresponding desired values is possible. Thus, not only differences in the compression springs, but, for example, capillary errors can be compensated by means of the spacer ring 9a. The compensation is done by adjusting the biasing force of the compression spring 8 by means of the easily replaceable spacer ring 9a.
  • the spacer ring 9a is therefore available for a device type in different strengths, and it is used in the assembly of the device of the spacer ring, which has the optimal strength for the compensation.
  • the container 1 is filled with the product, and the delivery piston 2 accordingly assumes its distal position in the container 1. Accordingly, the output piston 6 also assumes its distal position in the inner sleeve 4b. In this distal position, the output piston 6 ideally terminates with the rear end face of the inner sleeve 4b in order to keep the overall length of the device as short as possible.
  • the fluid compartment 22 has its smallest volume in this state of the device. Accordingly, the fluid compartment 21 has its largest volume.
  • the output piston 6 is held in its distal position either directly by the user or preferably by means of a lock. At the same time, the drive piston 5 assumes its proximal position.
  • the compression spring 8 is tensioned in this proximal position of the drive piston 5 between the two surfaces, formed by the shoulder surface of the drive piston 5 and the spacer ring 9a.
  • the locking of the output piston 6 or the piston rod 7 is released after the insertion of a needle attached to the proximal end of the catheter 20.
  • a fluid pressure is built up by the drive piston 5 in the fluid compartment 21. This fluid pressure can be reduced only by the capillary 23.
  • the drive piston 5 Under the pressure of the drive piston 5, fluid flows from the fluid compartment 21 through the capillary 23 into the fluidic compartment 22.
  • the output piston 6 is displaced in the proximal direction.
  • the fluid subspace 21 thus forms a drive side and the fluid subspace 22 an output side of the fluid chamber 21, 22 in total. More specifically, the drive side are formed by a piston area of the drive piston 5 facing the fluid compartment 21 and the output side by a piston area of the output piston 6 facing the fluid compartment 22.
  • a pressure reducing device is formed in the embodiment by the capillary body 10, the outer sleeve 3 and the capillary 23 formed in cooperation. By this pressure reducing a structurally predetermined pressure drop is effected. Due to the generated pressure drop, it is possible to use a stronger compression spring 8 for driving the delivery piston 2 than would be possible with an unthrottled drive.
  • the piston surface of the drive piston 5 is larger than the piston surface of the output piston 6. Accordingly causes a stroke of the drive piston 5 a contrast, larger stroke of the output piston 6.
  • the output piston 6 in turn acts A full stroke of the output piston 6 correspondingly corresponds to the stroke of the delivery piston 2.
  • the stroke of the delivery piston 2 in turn is predetermined by the containers 1 commonly used.
  • the full stroke of the delivery piston 2, which corresponds to a complete discharge of the contents of the container 1, is compared to a much shorter working stroke of the drive piston 5 and thus the compression spring 8 against.
  • the delivery piston 2 is charged for its own drive with a pressure of about one bar, i. he exerts such a pressure on the contents of the container 1.
  • the fluid coupling is designed to transmit the force of the compression spring 8 from the drive side of the fluid space 21, 22 to the output side. This is done essentially by the pressure reducing device, which is formed by the outer sleeve 3, the capillary body 10 and the capillary 23, and by the size ratio of the two piston surfaces of the pistons 5 and 6.
  • the container 1 can be refilled for re-administration or preferably replaced with a filled, new container.
  • the delivery piston 2 is retracted by means of the piston rod 7 into the starting position shown in FIG. In the initial position, the piston rod 7 is locked by a suitable blocking agent.
  • the output piston 6 presses the fluid from the completely filled fluid compartment 22 into the fluid compartment 21. In this case, the fluid flows from the interior of the inner sleeve 4b through the opening 14 in the bottom of the capillary body 10 and over a small gap between the cap 19 and the capillary body 10 to the check valve 11, 12, 13.

Abstract

The invention relates to a device for administering an injectable product, comprising: a) a casing (3); b) a container for said product accommodated by said casing (3) c) a delivering means (2) for delivering product out of said container (1); d) a drive means (8); and e) a transmission link via which said drive means (8) drives said delivering means (2). The device is characterised in that: f) a fluid space (21, 22) for an incompressible fluid and g) a pressure reducing means (3, 10, 23) are provided in said transmission link; h) wherein said fluid space (21, 22) can be impinged on a drive side by pressure from said drive means (8) and said pressure reducing means (3, 10, 23) reduces a fluid pressure generated by said drive means (8) toward a driven side of said fluid space (21, 22).

Description

Die Erfindung betrifft eine Vorrichtung zur Verabreichung eines injizierbaren Produkts.The invention relates to a device for administering an injectable product.

Injektionsgeräte, beispielsweise Injektionsspritzen oder Injektionspens, wie die Erfindung sie insbesondere, jedoch nicht ausschließlich betrifft, weisen üblicherweise ein Gehäuse auf, in dem eine Ampulle mit dem zu injizierenden Produkt, ein Fördermittel zur Förderung des Produkts aus der Ampulle, ein Antriebsmittel und eine Kopplungseinrichtung aufgenommen sind. Das Fördermittel wird üblicherweise durch einen in der Ampulle verschiebbaren Kolben gebildet. Als Antriebsmittel dient bei einfachen Spritzen die Muskelkraft des Benutzers. Bekannt ist auch die Verwendung von Federelementen, insbesondere von Druckfedern, als Antriebsmittel. Die Kopplungseinrichtung bildet eine Übertragungsstrecke bzw. Antriebsverbindung von dem Antriebsmittel zu dem Fördermittel.Injection devices, for example hypodermic syringes or injection pens, of which the invention is particularly but not exclusively concerned, usually comprise a housing in which an ampoule containing the product to be injected, a delivery means for conveying the product from the ampoule, a drive means and a coupling device are received are. The conveying means is usually formed by a piston displaceable in the ampoule. The driving force used in simple syringes is the muscle power of the user. Also known is the use of spring elements, in particular of compression springs, as a drive means. The coupling device forms a transmission path or drive connection from the drive means to the conveying means.

Die bekannten Antriebsmittel, beispielsweise Antriebsfedern, besitzen den Nachteil, dass die von ihnen aufgebrachte Antriebskraft oder Antriebsenergie im Verlaufe ihrer Freisetzung Änderungen unterliegt. Bei Antriebsfedern ändert sich die Antriebsenergie entsprechend der Federcharakteristik. Die Förderrate des Fördermittels folgt solchen Änderungen. Dementsprechend ändert sich im Verlaufe einer Ausschüttung des Produkts die Ausschüttrate entsprechend der sich ändernden Antriebsenergie.The known drive means, for example drive springs, have the disadvantage that the drive force or drive energy applied by them is subject to changes in the course of their release. With drive springs, the drive energy changes according to the spring characteristic. The delivery rate of the conveyor follows such changes. Accordingly, in the course of a discharge of the product, the Ausschüttrate changes according to the changing drive power.

Die US 5,788,673 offenbart ein Infusionssystem für eine Flüssigkeit, das eine Pumpvorrichtung und eine Spritze umfasst. In der Pumpvorrichtung treibt ein Antriebskolben einen Abtriebskolben über ein Fluid an. Eine Drossel hemmt das Fluid, um von einer Kammer, aus der das Fluid mit dem Antriebskolben verdrängt wird, in eine andere Kammer zu laufen. In einer Ausführungsform sind die Kammern axial hintereinander, in einer anderen Ausführungsform nebeneinander angeordnet.US 5,788,673 discloses a fluid infusion system comprising a pumping device and a syringe. In the pumping device, a drive piston drives a driven piston via a fluid. A throttle inhibits the fluid to enter a chamber from which the fluid is displaced with the drive piston other chamber to run. In one embodiment, the chambers are arranged axially behind one another, in another embodiment next to one another.

Aufgabe der Erfindung ist es, eine Vorrichtung zur Verabreichung eines injizierbaren Produkts zu schaffen, mit der das Produkt im Verlaufe einer Injektion oder Infusion gleichmäßig ausgeschüttet wird.
Die Erfindung geht von einer Vorrichtung zur Verabreichung eines injizierbaren Produkts aus, die ein Gehäuse, ein von dem Gehäuse aufgenommenes Behältnis für das Produkt, ein Fördermittel, ein Antriebsmittel und eine Übertragungsstrecke bzw. Kopplungseinrichtung, umfasst. Mit dem Fördermittel wird unmittelbar das Produkt aus dem Behältnis gefördert. Das Antriebsmittel liefert die hierfür erforderliche Antriebsenergie, die in der Übertragungsstrecke bis zu dem Fördermittel übertragen wird, derart, dass die Fördereinrichtung zur Ausschüttung des Produkts von dem Antriebsmittel angetrieben wird.The object of the invention is to provide a device for administering an injectable product, with which the product is evenly distributed in the course of an injection or infusion.
The invention is based on a device for administering an injectable product comprising a housing, a container for the product accommodated by the housing, a conveying means, a drive means and a transmission line or coupling device. With the funding directly the product is conveyed out of the container. The drive means supplies the drive energy required for this, which is transmitted in the transmission path to the conveyor, such that the conveyor is driven to dispense the product from the drive means.

Vorzugsweise sind das Behältnis, das Fördermittel, das Antriebsmittel und die Übertragungsglieder der Übertragungsstrecke in dem Gehäuse angeordnet. Andere Anordnungen sind grundsätzlich jedoch ebenfalls möglich. Bei dem injizierbaren Produkt handelt es sich vorzugsweise um einen medizinischen oder kosmetischen Wirkstoff, insbesondere in Form einer flüssigen Wirkstofflösung. Ein prominentes Beispiel ist Insulin, das mit der Vorrichtung im Rahmen einer Diabetistherapie verabreicht wird. Die Vorrichtung ist vorzugsweise ein Infusionsgerät. Es kann sich aber auch um ein Injektionsgerät handeln. Das Behältnis kann insbesondere als Ampulle ausgebildet sein, wie dies bei bekannten Infusionsgeräten der Fall ist. Das Fördermittel wird vorzugsweise durch einen in dem Behältnis aufgenommenen Kolben gebildet, der zur Ausschüttung von Produkt auf einen Auslass des Behältnisses zu vorgeschoben wird. Anstatt solch eines Kolbens kann das Fördermittel jedoch grundsätzlich durch jede zur Förderung des Produkts geeignete Pumpenart gebildet werden.Preferably, the container, the conveying means, the drive means and the transmission members of the transmission path are arranged in the housing. However, other arrangements are also possible in principle. The injectable product is preferably a medicinal or cosmetic active ingredient, in particular in the form of a liquid active substance solution. A prominent example is insulin administered with the device as part of diabetes therapy. The device is preferably an infusion device. It can also be an injection device. The container may in particular be designed as an ampoule, as is the case with known infusion devices. The conveying means is preferably formed by a piston accommodated in the container, which is advanced towards the discharge of product to an outlet of the container. However, instead of such a piston, the conveying means may basically be formed by any type of pump suitable for conveying the product.

Das Antriebsmittel ist seiner Art nach vorzugsweise derart ausgebildet, dass es bei seiner Auslösung eine in sich selbst gespeicherte Energie freisetzt. Durch eine Kopplungseinrichtung wird diese freigesetzte Energie in der Übertragungsstrecke bis zum Fördermittel übertragen, das seinerseits derart angetrieben das Produkt aus dem Behältnis fördert. Das Antriebsmittel wird vorzugsweise durch eine Antriebsfeder gebildet, besonders bevorzugt ist es eine Druckfeder. Grundsätzlich können jedoch auch andere Bauarten von Antriebsmitteln zum Einsatz kommen, z. B. solche, die ein Druckgas bei Ihrer Auslösung freisetzen.The drive means is preferably designed in such a way that it releases a self-stored energy when it is triggered. By a coupling device, this energy released in the transmission path to the Transfer funds transmitted in turn so powered the product from the container. The drive means is preferably formed by a drive spring, more preferably it is a compression spring. In principle, however, other types of drive means can be used, for. For example, those that release a pressurized gas in their release.

Nach der Erfindung sind in der Übertragungsstrecke von dem Antriebsmittel zu dem Fördermittel, d.h. in der Kopplungseinrichtung, ein Fluidraum für ein inkompressibles Fluid und eine Druckreduziereinrichtung vorgesehen. Der Fluidraum weist dementsprechend eine Antriebsseite, auf die das Antriebsmittel wirkt, und eine Abtriebsseite auf, die auf das Fördermittel wirkt. Sowohl die Antriebsseite als auch die Abtriebsseite können unmittelbar oder erst über weitere Übertragungsglieder mit dem Antriebsmittel bzw. dem Fördermittel verbunden sein. Der Fluidraum ist an seiner Antriebsseite von dem Antriebsmittel mit Druck beaufschlagbar. Der so erzeugte Druck wird von der Druckreduziereinrichtung zu der Abtriebsseite des Fluidraums hin gemindert. Vorzugsweise wird der Druck auf ein Fünftel oder weniger und besonders bevorzugt auf ein Zehntel oder weniger mittels der Druckreduziereinrichtung gemindert. Durch die Druckreduziereinrichtung wird eine Fluidverbindung geschaffen, die einen Fluidfluss von der Antriebsseite in Richtung Abtriebsseite nur verzögert zulässt, so dass im dynamischen Zustand, d. h. während des Antriebs des Fördermittels, an der Antriebsseite ein größerer Fluiddruck als an der Abtriebsseite herrscht.According to the invention, in the transmission path from the drive means to the conveyor, i. provided in the coupling device, a fluid space for an incompressible fluid and a pressure reducing device. The fluid space accordingly has a drive side to which the drive means acts and an output side which acts on the conveyance. Both the drive side and the output side can be connected directly or only via further transmission elements to the drive means or the conveyor. The fluid space can be acted upon by pressure on the drive side of the drive means. The pressure thus generated is reduced from the pressure reducing means to the output side of the fluid space. Preferably, the pressure is reduced to one fifth or less, and more preferably one tenth or less, by means of the pressure reducing means. By the pressure reducing device, a fluid connection is created, which allows a flow of fluid from the drive side in the direction of the output side only delayed, so that in the dynamic state, d. H. during the drive of the conveyor, there is a greater fluid pressure on the drive side than on the output side.

Die Erfindung ermöglicht den Einsatz eines Antriebsmittels, in dem eine wesentlich größere Energie gespeichert ist als zum Antrieb des Fördermittels und der damit einhergehenden Ausschüttung des Produkts erforderlich wäre. Die bei der Auslösung des Antriebsmittels freigesetzte, vergleichsweise große Antriebsenergie wird durch die erfindungsgemäße Fluidkopplung auf das für die Ausschüttung und Verabreichung erforderliche Maß herabgesetzt. Das Übermaß an Antriebsenergie steht wegen der erfindungsgemäßen Fluidkopplung kontrolliert für den Antrieb des Fördermittels zur Verfügung. Wird als Antriebsmittel eine Antriebsfeder verwendet, wie dies bevorzugt ist, so kann die Federstärke dieses Antriebsmittels erheblich größer sein als im Falle einer direkten Antriebsverbindung mit dem Fördermittel. Insbesondere kann solch eine Antriebsfeder in einem kleineren Bereich ihrer Federkennlinie betrieben werden als dies im Falle einer direkten Kopplung möglich wäre.The invention enables the use of a drive means in which a much larger energy is stored than would be required to drive the conveyor and the associated distribution of the product. The relatively large drive energy released when the drive means is released is reduced to the level required for distribution and administration by the fluid coupling according to the invention. The excess of drive energy is controlled because of the fluid coupling according to the invention for the drive of the conveyor available. If a drive spring is used as drive means, as is preferred, then the spring strength of this drive means can be considerably greater than in the case of a direct drive connection with the conveyor. In particular, such a Drive spring can be operated in a smaller range of their spring characteristic than would be possible in the case of a direct coupling.

Besonders bevorzugt wird durch die Fluidkopplung ein Arbeitshub des Antriebsmittels in einen Arbeitshub des Fördermittels übertragen, der größer als der Arbeitshub des Antriebsmittels ist. Im Falle einer Druck- oder Zugfeder als Antriebsmittel und eines Kolbens als Fördermittel ist der jeweilige Arbeitshub die Dehnung oder Stauchung der Feder und die in Abhängigkeit von diesem Arbeitshub von dem Kolben zurückgelegte Wegstrecke.Particularly preferably, a working stroke of the drive means is transferred by the fluid coupling in a working stroke of the conveying means, which is greater than the working stroke of the drive means. In the case of a compression or tension spring as a drive means and a piston as a conveyor of each working stroke is the elongation or compression of the spring and the distance traveled by the piston as a function of this stroke.

Besonders bevorzugt ist das Fördermittel als Kolben ausgebildet und das Antriebsmittel wirkt ebenfalls auf einen Kolben, der im folgenden als Antriebskolben bezeichnet wird. Die Antriebsseite des Fluidraums wird in dieser Ausführung von einer Kolbenfläche des Antriebskolbens gebildet. Die Kolbenfläche des Antriebskolbens ist vorzugsweise größer als eine Kolbenfläche eines Abtriebskolbens, wobei die Kolbenfläche des Abtriebskolbens die Abtriebsseite des Fluidraums bildet.Particularly preferably, the conveyor is designed as a piston and the drive means also acts on a piston, which is referred to below as the drive piston. The drive side of the fluid space is formed in this embodiment by a piston surface of the drive piston. The piston area of the drive piston is preferably larger than a piston area of an output piston, with the piston area of the output piston forming the output side of the fluid space.

Durch dieses Verhältnis der beiden Kolbenflächen wird ein Hub des Antriebskolbens in einen demgegenüber größeren Hub des Abtriebskolbens übertragen. Anders ausgedrückt, es ist zur Erzielung eines bestimmten Hubs des Abtriebskolbens ein kleinerer Hub des Antriebskolbens erforderlich. Dementsprechend kurz kann der Arbeitshub des Antriebsmittels gehalten werden. Das Antriebsmittel kann in einem engen Bereich um seinen optimalen Arbeitspunkt betrieben werden. Ferner findet durch die unterschiedlich großen Kolbenflächen eine Kranreduzierung statt. Es wird die von dem Antriebskolben ausgeübte Kraft entsprechend dem Flächenverhältnis von Antriebskolben und Abtriebskolben reduziert. Diese Reduzierung erfolgt zusätzlich zur Kranreduzierung infolge der Druckreduzierung.By this ratio of the two piston surfaces, a stroke of the drive piston is transmitted in a contrast greater stroke of the output piston. In other words, it is necessary to achieve a certain stroke of the output piston, a smaller stroke of the drive piston. Accordingly short, the power stroke of the drive means can be maintained. The drive means can be operated in a narrow range around its optimum operating point. Furthermore, a crane reduction takes place due to the different sized piston surfaces. The force exerted by the drive piston is reduced in accordance with the area ratio of drive piston and output piston. This reduction is in addition to the crane reduction due to the pressure reduction.

Der Abtriebskolben kann das Fördermittel unmittelbar bilden. Vorzugsweise handelt es sich bei dem Abtriebskolben jedoch um einen anderen Kolben.The output piston can form the conveyor directly. Preferably, however, the output piston is a different piston.

Der Fluidraum ist in einen die Antriebsseite umfassenden ersten Teilraum und einen die Antriebsseite umfassenden zweiten Teilraum unterteilt. Der erste Teilraum oder der zweite Teilraum ist als Ringkammer zwischen einer äußeren Hülse und einer inneren Hülse und der andere der beiden Teilräume in der inneren Hülse ausgebildet.The fluid space is subdivided into a first subspace comprising the drive side and a second subspace comprising the drive side. The first subspace or the second subspace is formed as an annular chamber between an outer sleeve and an inner sleeve and the other of the two subspaces in the inner sleeve.

In einem besonders bevorzugten Ausführungsbeispiel sind die beiden Teilräume ausschließlich durch ein Kapillarensystem miteinander verbunden, falls auf der Antriebsseite ein höherer Druck als auf der Abtriebsseite des Fluidraums herrscht. Das Kapillarensystem kann durch eine einzige oder auch durch mehrere Kapillaren gebildet werden.In a particularly preferred embodiment, the two subspaces are interconnected exclusively by a capillary system, if there is a higher pressure on the drive side than on the output side of the fluid space. The capillary system can be formed by a single or by a plurality of capillaries.

Die Kapillare oder die mehreren Kapillaren ist oder sind vorteilhafterweise möglichst lang. Vorzugsweise beträgt ihre Länge wenigstens 0,5 m. Sind mehrere Kapillaren ausgebildet, so gilt dies vorzugsweise für jede der Kapillaren. Die Durchflussrate ist bei langen Kapillaren weniger von dem Durchmesser der Kapillare abhängig, wie sich ohne weiteres aus dem Gesetz von Hagen-Poiseuille ergibt. Nach dem Gesetz von Hagen-Poiseuille gehen nämlich Schwankungen des Durchmessers aufgrund von Fertigungsungenauigkeiten in der vierten Potenz in die Durchflussrate ein. Mit zunehmender Länge der Kapillare kann jedoch ihr Durchmesser ebenfalls vergrößert werden, wenn die Durchflussrate konstant bleiben soll. Größere Durchmesser sind zum einen von Hause aus einfacher herstellbar als kleinere Durchmesser, und mit zunehmender Größe des Durchmessers schlagen Abweichungen vom Solldurchmesser zunehmend weniger zu Buche. Ferner wird eine möglichst hohe Viskosität des Arbeitsfluids im Fluidraum bevorzugt.The capillary or the plurality of capillaries is or are advantageously as long as possible. Preferably, their length is at least 0.5 m. If several capillaries are formed, this preferably applies to each of the capillaries. The flow rate of long capillaries is less dependent on the diameter of the capillary, as is readily apparent from Hagen-Poiseuille's law. According to the law of Hagen-Poiseuille, variations in diameter due to manufacturing inaccuracies in the fourth power in the flow rate. However, as the capillary length increases, its diameter can also be increased if the flow rate is to remain constant. Larger diameters are on the one hand easier to produce from home than smaller diameters, and with increasing size of the diameter deviations from the nominal diameter increasingly less to book. Furthermore, the highest possible viscosity of the working fluid in the fluid space is preferred.

Das Kapillarensystem weist vorzugsweise eine spiralig verlaufende Kapillare oder mehrere solcher Kapillaren auf. In einem bevorzugten Ausführungsbeispiel wird das Kapillarensystem durch eine einzige, spiralige Kapillare gebildet. Eine spiralige Kapillare bringt nicht nur den Vorteil einer großen Länge mit sich, sondern kann auch einfach hergestellt werden. Sie kann insbesondere in Form eines Außen- oder Innengewindes an einer entsprechenden Mantelfläche eines Kapillarenkörpers gebildet sein. Der Kapillarenkörper mit dem Außen- oder Innengewinde wird vorzugsweise in oder auf einen weiteren Körper mit einer glatten Gegenmantelfläche gesteckt, wobei darauf zu achten ist, dass die Gewindegänge des Kapillarenkörpers an der Gegenmantelfläche gegeneinander abgedichtet sind.The capillary system preferably has a spirally extending capillary or several such capillaries. In a preferred embodiment, the capillary system is formed by a single, spiral capillary. A spiral capillary not only brings the advantage of a long length, but can also be easily manufactured. It can be formed in particular in the form of an external or internal thread on a corresponding lateral surface of a capillary body. The capillary body with the external or internal thread is preferably inserted in or on another body with a smooth mantle surface, care being taken to that the threads of the capillary body are sealed against each other on the mantle surface.

Die Erfindung wird nachfolgend anhand eines bevorzugten Ausrührungsbeispiels beschrieben. Es zeigen:

Figur 1
ein Infusionsgerät in einem Längsschnitt,
Figur 2
eine Kapillare gemäß Detail I der Figur 1 und
Figur 3
eine alternative Ausführungsform einer Kapillare.
The invention will be described below with reference to a preferred Ausrührungsbeispiels. Show it:
FIG. 1
an infusion device in a longitudinal section,
FIG. 2
a capillary according to detail I of Figure 1 and
FIG. 3
an alternative embodiment of a capillary.

Figur 1 zeigt im Längsschnitt ein Infusionsgerät.FIG. 1 shows a longitudinal section of an infusion device.

Eine kreiszylindrische äußere Hülse 3 bildet zusammen mit einem Verschlussstück 9 an einem proximalen Ende und einer Verschlusskappe 19 an einem distalen Ende ein Gehäuse des Infusionsgeräts. Ein Behältnishalter 4a ist in einem proximalen Bereich der äußeren Hülse 3 zentriert gehalten. In dem Behältnishalter 4a ist ein Behältnis 1 in Form einer Ampulle ebenfalls zentriert zur Mittellängsachse der äußeren Hülse 3 aufgenommen. Das Behältnis 1 ist mit einem zu injizierenden Produkt, beispielsweise Insulin, gefüllt. In dem Behältnis 1 ist ferner ein Fördermittel 2 in Form eines Förderkolbens geradlinig auf einen Auslass des Behältnisses 1 zu verschiebbar aufgenommen. An den Auslass des Behältnisses 1 ist ein Katheter 20 in an sich bekannter Art und Weise angeschlossen.A circular cylindrical outer sleeve 3 forms, together with a closure piece 9 at a proximal end and a closure cap 19 at a distal end, a housing of the infusion device. A container holder 4a is kept centered in a proximal portion of the outer sleeve 3. In the container holder 4a a container 1 in the form of an ampoule is also centered to the central longitudinal axis of the outer sleeve 3 added. The container 1 is filled with a product to be injected, for example insulin. In the container 1, a conveyor 2 in the form of a delivery piston is further received in a straight line to an outlet of the container 1 to be displaced. At the outlet of the container 1, a catheter 20 is connected in a conventional manner.

In einem distalen Bereich des Infusionsgeräts ist eine innere Hülse 4b konzentrisch zu der äußeren Hülse 3 angeordnet. Im Ausführungsbeispiel sind der Behältnishalter 4a und die innere Hülse 4b als einstückige Hülse ausgebildet. Der Behältnishalter 4a und die innere Hülse 4b könnten auch separate Bauteile sein. Durch die einstückige Ausbildung wird jedoch die gemeinsame, zentrierte Halterung in der äußeren Hülse 3 vereinfacht, wie sich aus Figur 1 und der nachfolgenden Beschreibung ohne weiteres erschließt.In a distal region of the infusion device, an inner sleeve 4b is arranged concentrically with the outer sleeve 3. In the embodiment, the container holder 4a and the inner sleeve 4b are formed as a one-piece sleeve. The container holder 4a and the inner sleeve 4b could also be separate components. Due to the one-piece design, however, the common, centered mounting in the outer sleeve 3 is simplified, as can be seen from FIG. 1 and the following description.

Eine Innenmantelfläche der inneren Hülse 4b bildet eine Gleitführung für einen in der inneren Hülse 4b aufgenommenen Abtriebskolben 6, der mittels einer Kolbenstange 7 mit dem Förderkolben 2 steif verbunden ist. Der Abtriebskolben 6 und die Kolbenstange 7 sind einstückig ausgebildet. Die Kolbenstange 7 stößt an den Förderkolben 2 an. Sie könnte auch fest mit dem Förderkolben verbunden sein; beispielsweise könnte sie mit dem Förderkolben 2 verschraubt sein. Ferner kann die Kolbenstange 7 in einem Halsbereich zwischen dem Behältnishalter 4a und der inneren Hülse 4b ebenfalls gleitgeführt sein, beispielsweise fluiddicht gleitgeführt. Der Abtriebskolben 6 dichtet mit Dichtringen 17 in der Art von Kolbenringen zur inneren Hülse 4b hin ab.An inner circumferential surface of the inner sleeve 4b forms a sliding guide for a driven piston 6 accommodated in the inner sleeve 4b, which is rigidly connected to the delivery piston 2 by means of a piston rod 7. The output piston 6 and the piston rod 7 are integrally formed. The piston rod 7 abuts the delivery piston 2. You could also be firmly connected to the delivery piston; For example, it could be bolted to the delivery piston 2. Further, the piston rod 7 may also be slidably guided in a neck region between the container holder 4a and the inner sleeve 4b, for example, guided in a fluid-tight manner. The output piston 6 seals with sealing rings 17 in the manner of piston rings to the inner sleeve 4b down.

Zwischen der äußeren Hülse 3 und der inneren Hülse 4b ist ein Ringraum gebildet, in dem ein Antriebskolben 5 angeordnet ist. Der Antriebskolben 5 ist ein Ringkolben, der in dem Ringraum zwischen der äußeren Hülse 3 und der inneren Hülse 4b hin und her fluiddicht und eng gleitgeführt wird. In Nuten in einer Innenmantelfläche des Antriebskolbens 5 sind Dichtringe 15 und in Nuten an einer Außenmantelfläche des Antriebskolbens 5 sind weitere Dichtringe 16, jeweils in der Art von Kolbenringen, aufgenommen. Der Antriebskolben 5 weist an einer distalen Stirnseite eine plane Ringfläche auf. In die proximale Richtung verjüngt sich der Antriebskolben 5 zur inneren Hülse 4b hin. Die Verjüngung wird mittels einer Schulter gebildet. Der Schulter liegt in proximaler Richtung gesehen eine Gegenfläche des Infusionsgeräts gegenüber. Die Gegenfläche wird von einem Distanzstück in Form eines Distanzrings 9a gebildet, der den Behältnishalter 4a umgibt und auf dem Verschlussstück 9 lose aufliegt.Between the outer sleeve 3 and the inner sleeve 4b, an annular space is formed, in which a drive piston 5 is arranged. The drive piston 5 is an annular piston which is fluid-tightly and tightly slid in the annular space between the outer sleeve 3 and the inner sleeve 4b. In grooves in an inner circumferential surface of the drive piston 5 are sealing rings 15 and in grooves on an outer circumferential surface of the drive piston 5 are further sealing rings 16, each in the manner of piston rings, added. The drive piston 5 has a flat annular surface on a distal end face. In the proximal direction, the drive piston 5 tapers toward the inner sleeve 4b. The rejuvenation is formed by means of a shoulder. The shoulder is in the proximal direction opposite to a counter surface of the infusion device. The mating surface is formed by a spacer in the form of a spacer 9a, which surrounds the container holder 4a and rests loosely on the closure piece 9.

In einem Ringraum zwischen der äußeren Hülse 3 einerseits und dem Behältnishalter 4a und der inneren Hülse 4b andererseits ist zwischen den beiden einander gegenüberliegenden Flächen, nämlich der Schulter des Antriebskolbens 5 und dem Distanzring 9a, eine Druckfeder 8 an beide Flächen anstoßend aufgenommen. Durch Variation der Stärke des Distanzrings 9a, d.h. durch Distanzringwechsel, kann die Vorrichtung auf einfache Art und Weise an unterschiedliche Druckfedern 8 angepasst werden, um den Federarbeitsbereich stets optimal einzustellen.In an annular space between the outer sleeve 3 on the one hand and the container holder 4a and the inner sleeve 4b on the other hand, a compression spring 8 is added abutting both surfaces between the two opposing surfaces, namely the shoulder of the drive piston 5 and the spacer ring 9a. By varying the thickness of the spacer ring 9a, i. by spacer ring change, the device can be adapted to different compression springs 8 in a simple manner to always optimally adjust the spring working range.

In distaler Richtung ist hinter dem Antriebskolben 5 ein Kapillarenkörper 10 angeordnet. Der Kapillarenkörper 10 weist einen proximalen Ringbereich auf und schließt an seinem distalen Ende mit einem Boden ab. Im Bereich seines Ringkörpers dichtet der Kapillarenkörper 10 gegen die äußere Hülse 3 und vorzugsweise auch gegen die innere Hülse 4b fluiddicht ab. Eine distale Stirnfläche der inneren Hülse 4b drückt über einen Dichtring 18 fluiddicht gegen den Boden des Kapillarenkörpers 10. Im Bereich einer distalen, stirnseitigen Öffnung der inneren Hülse 4b, die von dem Dichtring 18 abgedichtet wird, ist der Kapillarenkörper 10 mit einer Durchlassöffnung 14 versehen.In the distal direction behind the drive piston 5, a capillary body 10 is arranged. The capillary body 10 has a proximal annular region and terminates at its distal end with a bottom. In the region of its annular body, the capillary body 10 seals against the outer sleeve 3 and preferably also against the inner Sleeve 4b fluid-tight. A distal end face of the inner sleeve 4b presses against the bottom of the capillary body 10 in a fluid-tight manner via a sealing ring 18. In the region of a distal end opening of the inner sleeve 4b, which is sealed by the sealing ring 18, the capillary body 10 is provided with a passage opening 14.

In dem Kapillarenkörper 10 ist ein in nur einer Richtung offener Durchlass durch ein Rückschlagventil gebildet. Das Rückschlagventil weist eine Ventilkugel 11 auf, die in bekannter Weise mittels einer Ventilfeder 12 in ihren Sitz innerhalb des Kapillarenkörpers 10 gepresst wird. Die Ventilfeder 12 wiederum ist an einem Ventilverschluss 13 abgestützt.In the capillary body 10, a passage open in only one direction is formed by a check valve. The check valve has a valve ball 11, which is pressed in a known manner by means of a valve spring 12 into its seat within the capillary body 10. The valve spring 12 in turn is supported on a valve closure 13.

Zwischen der distalen Stimfläche des Antriebskolbens 5 und einer distalen Stimfläche des Abtriebskolbens 6 ist ein fluiddicht durch diese beiden Kolben 5 und 6 abgeschlossener Fluidraum mit einem ersten Teilraum 21 und einem zweiten Teilraum 22 gebildet. Die beiden Teilräume 21 und 22 sind durch den Kapillarenkörper 10 voneinander getrennt. Der Fluidraum 21, 22 ist mit einem inkompressiblen Arbeitsfluid vollkommen gefüllt. Als Arbeitsfluid wird vorzugsweise ein hochviskoses Öl verwendet.Between the distal end face of the drive piston 5 and a distal end face of the output piston 6, a fluid space sealed by these two pistons 5 and 6 is formed with a first subspace 21 and a second subspace 22. The two subspaces 21 and 22 are separated from each other by the capillary body 10. The fluid space 21, 22 is completely filled with an incompressible working fluid. As the working fluid, a high-viscosity oil is preferably used.

Das Rückschlagventil 11, 12, 13 erlaubt einen Durchfluss des Arbeitsfluids nur von dem Teilraum 22 in den Teilraum 21 und verhindert einen Durchfluss in die andere Richtung.The check valve 11, 12, 13 allows a flow of the working fluid only from the subspace 22 in the subspace 21 and prevents flow in the other direction.

Der Kapillarenkörper 10 bildet mit einer ihn umschließenden Innenmantelfläche der äußeren Hülse 3 eine Fluidverbindung in Form eines Kapillarensystems. Das Kapillarensystem ist im Detail I der Figur 2 dargestellt. Es wird durch einen einzigen zusammenhängenden Fluidkanal, nämlich eine Kapillare 23, gebildet. Die Kapillare 23 läuft in Form eines mehrgängigen Gewindes spiralig um die äußere Mantelfläche des Kapillarenkörpers 10 um. Die Kapillare 23 kann grundsätzlich auch durch einen einzigen Gewindegang gebildet sein. Sie verbindet im Einbauzustand des Kapillarenkörpers 10 die beiden Fluidteilräume 21 und 22. Die der Kapillare 23 gegenüberliegende Innenmantelfläche der äußeren Hülse 3 ist einfach glatt. Der Kapillarenkörper 10 wird unter leichtem Pressdruck in die äußere Hülse 3 hineingeschoben. Die "Zähne" an der äußeren Mantelfläche des Kapillarenkörpers 10, die die einzelnen Gänge der Kapillare 23 voneinander trennen, drücken im eingebauten Zustand fluiddicht gegen die Innenmantelfläche der äußeren Hülse 3. Die Zähne des Kapillarenkörpers 10 sind zu Dichtzwecken abgeflacht. Der Kapillarenkörper 10 besteht aus einem weicheren Material als die äußere Hülse 3, um die Abdichtung zu verbessern. Grundsätzlich könnte jedoch zum gleichen Zweck auch die äußere Hülse 3 aus einem weicheren Material als der Kapillarenkörper 10 gefertigt sein.The capillary body 10 forms a fluid connection in the form of a capillary system with a surrounding inner circumferential surface of the outer sleeve 3. The capillary system is shown in detail I of Figure 2. It is formed by a single continuous fluid channel, namely a capillary 23. The capillary 23 runs in the form of a multi-thread thread spirally around the outer surface of the capillary body 10. The capillary 23 can in principle also be formed by a single thread. It connects in the installed state of the capillary body 10, the two fluid subspaces 21 and 22. The capillary 23 opposite inner lateral surface of the outer sleeve 3 is simply smooth. The capillary body 10 is pushed into the outer sleeve 3 under slight pressure. The "teeth" on the outer surface of the capillary body 10, the individual passages of the capillary 23rd separate from each other, press in the installed state fluid-tight against the inner circumferential surface of the outer sleeve 3. The teeth of the capillary body 10 are flattened for sealing purposes. The capillary body 10 is made of a softer material than the outer sleeve 3 to improve the seal. In principle, however, the outer sleeve 3 could be made of a softer material than the capillary body 10 for the same purpose.

In Figur 3 ist eine alternative Ausgestaltung einer Kapillare 23 dargestellt. Die Kapillare 23 wird in diesem Fall in einem Einsatzstück als gerader Fluidkanal ausgebildet. Das Einsatzstück wird in einer Aufnahme des Kapillarenkörpers fluiddicht gehalten. In dem Kapillarenkörper 10 ist eine die Kapillare 23 des Einsatzstücks verlängernde Bohrung ausgebildet, so dass auch in diesem Ausführungsbeispiel mittels einer Kapillare 23 eine Fluidverbindung zwischen den beiden Teilräumen 21 und 22 geschaffen wird.FIG. 3 shows an alternative embodiment of a capillary 23. The capillary 23 is formed in this case in an insert as a straight fluid channel. The insert is kept fluid-tight in a receptacle of the capillary body. In the capillary body 10, the capillary 23 of the insert extending bore is formed, so that in this embodiment by means of a capillary 23, a fluid connection between the two sub-spaces 21 and 22 is created.

Durch das Einsetzen eines Distanzrings 9a ist eine einfache Kompensation von sämtlichen in der Übertragungsstrecke von der Druckfeder 8 bis zu dem Abtriebskolben 6 auftretenden Abweichungen von entsprechenden Sollwerten möglich. So können mittels des Distanzrings 9a nicht nur Unterschiede bei den Druckfedern, sondern beispielsweise auch Kapillarenfehler kompensiert werden. Die Kompensation erfolgt durch Einstellung der Vorspannkraft der Druckfeder 8 mittels des einfach austauschbaren Distanzrings 9a. Der Distanzring 9a liegt für einen Gerätetyp daher in unterschiedlichen Stärken vor, und es wird bei der Montage des Geräts der Distanzring eingesetzt, der die für die Kompensation optimale Stärke aufweist.By inserting a spacer ring 9a, a simple compensation of all occurring in the transmission path from the compression spring 8 to the output piston 6 deviations from corresponding desired values is possible. Thus, not only differences in the compression springs, but, for example, capillary errors can be compensated by means of the spacer ring 9a. The compensation is done by adjusting the biasing force of the compression spring 8 by means of the easily replaceable spacer ring 9a. The spacer ring 9a is therefore available for a device type in different strengths, and it is used in the assembly of the device of the spacer ring, which has the optimal strength for the compensation.

Die Funktionsweise des Infusionsgeräts wird nachfolgend beschrieben:The operation of the infusion device is described below:

In dem in Figur 1 dargestellten Zustand ist das Behältnis 1 mit dem Produkt gefüllt und der Förderkolben 2 nimmt dementsprechend seine distale Position in dem Behältnis 1 ein. Entsprechend nimmt auch der Abtriebskolben 6 seine distale Position in der inneren Hülse 4b ein. In dieser distalen Position schließt der Abtriebskolben 6 idealerweise mit der hinteren Stirnfläche der inneren Hülse 4b ab, um die Baulänge der Vorrichtung insgesamt so kurz als möglich zu halten.In the state shown in FIG. 1, the container 1 is filled with the product, and the delivery piston 2 accordingly assumes its distal position in the container 1. Accordingly, the output piston 6 also assumes its distal position in the inner sleeve 4b. In this distal position, the output piston 6 ideally terminates with the rear end face of the inner sleeve 4b in order to keep the overall length of the device as short as possible.

Der Fluidteilraum 22 weist in diesem Zustand der Vorrichtung sein kleinstes Volumen auf. Dementsprechend weist der Fluidteilraum 21 sein grösstes Volumen auf. Der Abtriebskolben 6 wird in seiner distalen Stellung entweder unmittelbar von dem Benutzer oder vorzugsweise mittels einer Arretierung gehalten. Gleichzeitig nimmt der Antriebskolben 5 seine proximale Position ein. Die Druckfeder 8 ist in dieser proximalen Position des Antriebskolben 5 zwischen den beiden Flächen, gebildet durch die Schulterfläche des Antriebskolbens 5 und den Distanzring 9a, gespannt.The fluid compartment 22 has its smallest volume in this state of the device. Accordingly, the fluid compartment 21 has its largest volume. The output piston 6 is held in its distal position either directly by the user or preferably by means of a lock. At the same time, the drive piston 5 assumes its proximal position. The compression spring 8 is tensioned in this proximal position of the drive piston 5 between the two surfaces, formed by the shoulder surface of the drive piston 5 and the spacer ring 9a.

Für eine subkutane Verabreichung des Produkts wird nach dem Einstechen einer an dem proximalen Ende des Katheters 20 angebrachten Injektionsnadel die Arretierung des Abtriebskolbens 6 bzw. der Kolbenstange 7 gelöst. Unter dem Druck der Druckfeder 8 wird durch den Antriebskolben 5 im Fluidteilraum 21 ein Fluiddruck aufgebaut. Dieser Fluiddruck kann ausschließlich durch die Kapillare 23 abgebaut werden. Unter dem Druck des Antriebskolbens 5 fließt Fluid aus dem Fluidteilraum 21 durch die Kapillare 23 hindurch in den Fluidteikaum 22. Durch den sich aufbauenden Druck im Fluidteilraum 22 wird der Abtriebskolben 6 in die proximale Richtung verschoben. Der Fluidteilraum 21 bildet somit eine Antriebsseite und der Fluidteilraum 22 eine Abtriebsseite des Fluidraums 21, 22 insgesamt. Genauer gesagt werden die Antriebsseite durch eine dem Fluidteilraum 21 zugewandte Kolbenfläche des Antriebskolbens 5 und die Abtriebsseite durch eine dem Fluidteilraum 22 zugewandte Kolbenfläche des Abtriebskolbens 6 gebildet.For a subcutaneous administration of the product, the locking of the output piston 6 or the piston rod 7 is released after the insertion of a needle attached to the proximal end of the catheter 20. Under the pressure of the compression spring 8, a fluid pressure is built up by the drive piston 5 in the fluid compartment 21. This fluid pressure can be reduced only by the capillary 23. Under the pressure of the drive piston 5, fluid flows from the fluid compartment 21 through the capillary 23 into the fluidic compartment 22. As a result of the pressure building up in the fluid compartment 22, the output piston 6 is displaced in the proximal direction. The fluid subspace 21 thus forms a drive side and the fluid subspace 22 an output side of the fluid chamber 21, 22 in total. More specifically, the drive side are formed by a piston area of the drive piston 5 facing the fluid compartment 21 and the output side by a piston area of the output piston 6 facing the fluid compartment 22.

Eine Druckreduziereinrichtung wird im Ausführungsbeispiel durch den Kapillarenkörper 10, die äußere Hülse 3 und die im Zusammenwirken gebildete Kapillare 23 ausgebildet. Durch diese Druckreduziereinrichtung wird ein konstruktiv vorgegebener Druckabfall bewirkt. Aufgrund des erzeugten Druckabfalls ist es möglich, eine stärkere Druckfeder 8 für den Antrieb des Förderkolbens 2 zu verwenden als dies bei einem ungedrosselten Antrieb möglich wäre.A pressure reducing device is formed in the embodiment by the capillary body 10, the outer sleeve 3 and the capillary 23 formed in cooperation. By this pressure reducing a structurally predetermined pressure drop is effected. Due to the generated pressure drop, it is possible to use a stronger compression spring 8 for driving the delivery piston 2 than would be possible with an unthrottled drive.

Darüber hinaus ist die Kolbenfläche des Antriebskolbens 5 größer als die Kolbenfläche des Abtriebskolbens 6. Dementsprechend bewirkt ein Hub des Antriebskolbens 5 einen demgegenüber größeren Hub des Abtriebskolbens 6. Der Abtriebskolben 6 wiederum wirkt unmittelbar mittels der steifen Kolbenstange 7 auf den Förderkolben 2. Ein voller Hub des Abtriebskolben 6 entspricht dementsprechend dem Hub des Förderkolbens 2. Der Hub des Förderkolbens 2 wiederum ist durch die üblicherweise verwendeten Behältnisse 1 vorgegeben. Dem vollen Arbeitshub des Förderkolbens 2, der einer vollständigen Ausschüttung des Inhalts des Behältnisses 1 entspricht, steht ein im Vergleich dazu wesentlich kürzerer Arbeitshub des Antriebskolbens 5 und damit der Druckfeder 8 gegenüber.In addition, the piston surface of the drive piston 5 is larger than the piston surface of the output piston 6. Accordingly causes a stroke of the drive piston 5 a contrast, larger stroke of the output piston 6. The output piston 6 in turn acts A full stroke of the output piston 6 correspondingly corresponds to the stroke of the delivery piston 2. The stroke of the delivery piston 2 in turn is predetermined by the containers 1 commonly used. The full stroke of the delivery piston 2, which corresponds to a complete discharge of the contents of the container 1, is compared to a much shorter working stroke of the drive piston 5 and thus the compression spring 8 against.

Konstruktiv interessant ist auch die konzentrische Anordnung der beiden Fluidteilräume 21 und 22 des Fluidgesamtraums 21, 22. Durch diese Anordnung kann die Baulänge der Vorrichtung insgesamt kurz gehalten werden.Of constructive interest is also the concentric arrangement of the two fluid subspaces 21 and 22 of the fluid total space 21, 22. By this arrangement, the overall length of the device can be kept short overall.

Der Förderkolben 2 wird für seinen eigenen Antrieb mit einem Druck von etwa ein bar belastet, d.h. er übt solch einen Druck auf den Inhalt des Behältnisses 1 aus. Die Fluidkopplung ist entsprechend ausgebildet, um die Kraft der Druckfeder 8 von der Antriebsseite des Fluidraums 21, 22 auf die Abtriebsseite zu übertragen. Dies erfolgt im wesentlichen durch die Druckreduziereinrichtung, die durch die äußere Hülse 3, den Kapillarenkörper 10 und die Kapillare 23 gebildet wird, und durch das Größenverhältnis der beiden Kolbenflächen der Kolben 5 und 6.The delivery piston 2 is charged for its own drive with a pressure of about one bar, i. he exerts such a pressure on the contents of the container 1. The fluid coupling is designed to transmit the force of the compression spring 8 from the drive side of the fluid space 21, 22 to the output side. This is done essentially by the pressure reducing device, which is formed by the outer sleeve 3, the capillary body 10 and the capillary 23, and by the size ratio of the two piston surfaces of the pistons 5 and 6.

Nach der Ausschüttung von Produkt, beispielsweise nach einer vollkommenen Entleerung, kann das Behältnis 1 für eine erneute Verabreichung wieder aufgefüllt oder vorzugsweise gegen ein gefülltes, neues Behältnis ausgetauscht werden. Vor dem Austausch wird der Förderkolben 2 mittels der Kolbenstange 7 in die in Figur 1 gezeigte Ausgangsstellung zurückgezogen. In der Ausgangsstellung wird die Kolbenstange 7 durch ein geeignetes Blockiermittel arretiert. Im Verlaufe des Zurückziehens drückt der Abtriebskolben 6 das Fluid aus dem vollständig gefüllten Fluidteilraum 22 in den Fluidteilraum 21. Dabei strömt das Fluid aus dem Innenraum der inneren Hülse 4b durch die Öffnung 14 in dem Boden des Kapillarenkörpers 10 und über einen kleinen Zwischenraum zwischen der Verschlusskappe 19 und dem Kapillarenkörper 10 zu dem Rückschlagventil 11, 12, 13. Unter dem Druck des Fluids in dem Fluidteilraum 22 öffnet das Rückschlagventil, und das Fluid strömt durch den mittels des Rückschlagventils gebildeten Durchfluss in den Fluidteilraum 21. Hierbei ist der Druck der Druckfeder 8 zu überwinden, um den Antriebskolben 5 in die proximale Richtung und schließlich in die gezeigte Ausgangsstellung vorzuschieben. Die Vorrichtung ist nun bereit für eine erneute Produktausschüttung.After the release of product, for example, after a complete emptying, the container 1 can be refilled for re-administration or preferably replaced with a filled, new container. Before replacement, the delivery piston 2 is retracted by means of the piston rod 7 into the starting position shown in FIG. In the initial position, the piston rod 7 is locked by a suitable blocking agent. In the course of the retraction, the output piston 6 presses the fluid from the completely filled fluid compartment 22 into the fluid compartment 21. In this case, the fluid flows from the interior of the inner sleeve 4b through the opening 14 in the bottom of the capillary body 10 and over a small gap between the cap 19 and the capillary body 10 to the check valve 11, 12, 13. Under the pressure of the fluid in the fluid compartment 22 opens the check valve, and the fluid flows through the flow formed by the check valve in the Fluidteilraum 21. In this case, the pressure of the compression spring 8 is overcome in order to advance the drive piston 5 in the proximal direction and finally in the initial position shown. The device is now ready for a new product distribution.

BezugszeichenlisteLIST OF REFERENCE NUMBERS

11
Behältnis, AmpulleContainer, ampoule
22
Fördermittel, FörderkolbenConveyor, delivery piston
33
Gehäuse, äußere HülseHousing, outer sleeve
4a4a
Behältnishaltercontainer holder
4b4b
innere Hülseinner sleeve
55
Antriebskolbendrive piston
66
Abtriebskolbendriven piston
77
Kolbenstangepiston rod
88th
Antriebsmittel, Antriebsfeder, DruckfederDrive means, drive spring, compression spring
99
Verschlussstückclosing piece
9a9a
Distanzstückspacer
1010
Trennkörper, KapillarenkörperSeparating body, capillary body
1111
Ventilkugelvalve ball
1212
Ventilfedervalve spring
1313
Ventilverschlussvalve closure
1414
DurchlassöffnungPort
1515
Dichtringeseals
1616
Dichtringeseals
1717
Dichtringeseals
1818
Dichtringseal
1919
Verschlusskappecap
2020
Kathetercatheter
2121
FluidteilraumFluid subarea
2222
FluidteilraumFluid subarea
2323
Fluidverbindung, Kapillarensystem, Fluidkanal, KapillareFluid connection, capillary system, fluid channel, capillary

Claims (11)

  1. A device for administering an injectable product, comprising:
    a) a casing (3);
    b) a container (1) for said product, accommodated by said casing (3);
    c) a delivering means (2) for delivering product out of said container (1);
    d) a drive means (8); and
    e) a transmission link via which said drive means (8) drives said delivering means (2);
    f) wherein a fluid space (21, 22) for an incompressible fluid
    g) and a pressure reducing means (3, 10, 23) are provided in said transmission link; and
    h) wherein said fluid space (21, 22) can be impinged on a drive side by pressure from said drive means (8), and said pressure reducing means (3, 10, 23) reduces a fluid pressure generated by said drive means (8) toward a driven side of said fluid space (21, 22);
    i) and said fluid space (21, 22) is sub-divided into a first partial space (21) including said drive side and a second partial space (22) including said driven side;
    characterised in that
    j) said first partial space or said second partial space is formed as a toroidal chamber between an outer sleeve (3) and an inner sleeve (4b), and the other of said two partial spaces (21, 22) is formed in said inner sleeve (4b).
  2. The device as set forth in claim 1, characterised in that a working stroke of said drive means (8) is transmitted in said fluid space (21, 22) into a working stroke of said delivering means (2) which is greater than the working stroke of said drive means (8).
  3. The device as set forth in the preceding claim, characterised in that a bias of said drive means (8) is determined by a replaceably arranged distance ring (9a).
  4. The device as set forth in any one of the preceding claims, characterised in that said drive side of said fluid space (21, 22) is formed by a piston area of a drive piston (5) which is larger than a piston area of a driven piston (6) which forms the driven side of said fluid space (21, 22).
  5. The device as set forth in any one of the preceding claims, characterised in that said two partial spaces (21, 22) are connected to each other by a fluid connection (23) formed by said pressure reducing means (3, 10, 23).
  6. The device as set forth in the preceding claim, characterised in that said two partial spaces (21, 22) are connected to each other exclusively by a system of capillaries (23), if a higher pressure prevails in said first partial space (21) than in said second partial space (22).
  7. The device as set forth in any one of the preceding two claims, characterised in that said fluid connection (23) includes a spiral fluid channel or is formed by the same.
  8. The device as set forth in the preceding claim, characterised in that said pressure reducing means (3, 10, 23) comprises a capillary body (10), and said spiral fluid channel is formed between a surface area of said capillary body (10) and an opposite surface area.
  9. The device as set forth in any one of the preceding claims, characterised in that:
    - said toroidal chamber forms said first partial space (21);
    - and a drive piston (5) guided fluid-proof by said outer sleeve (3) and said inner sleeve (4b) forms said drive side.
  10. The device as set forth in any one of the preceding claims, characterised in that:
    - said second partial space (22) is formed in said inner sleeve (4b);
    - and said driven piston (6) guided fluid-proof by said inner sleeve (4b) forms said driven side.
  11. The device as set forth in any one of the preceding claims, characterised in that:
    - said pressure reducing means (3, 10, 23) comprises a separating body (10) which forms a front face of said toroidal chamber and separates said two partial spaces (21, 22) from each other;
    - a valve (11, 12, 13) is accommodated in said separating body (10), said valve only allowing a flow of fluid from said driven side to said drive side of said fluid space (21, 22);
    - and in that said separating body (10) forms said fluid connection (23).
EP00941864A 1999-08-18 2000-07-18 Device for the administration of an injectable product Expired - Lifetime EP1210136B1 (en)

Applications Claiming Priority (3)

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DE19939023 1999-08-18
DE19939023A DE19939023A1 (en) 1999-08-18 1999-08-18 Device for administering an injectable product
PCT/CH2000/000390 WO2001012250A1 (en) 1999-08-18 2000-07-18 Device for the administration of an injectable product

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EP1210136A1 EP1210136A1 (en) 2002-06-05
EP1210136B1 true EP1210136B1 (en) 2006-01-25

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EP (1) EP1210136B1 (en)
JP (1) JP4274725B2 (en)
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US8361053B2 (en) 2006-03-30 2013-01-29 Valeritas, Inc. Multi-cartridge fluid delivery device
US9089636B2 (en) 2004-07-02 2015-07-28 Valeritas, Inc. Methods and devices for delivering GLP-1 and uses thereof

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US8070726B2 (en) 2003-04-23 2011-12-06 Valeritas, Inc. Hydraulically actuated pump for long duration medicament administration
US9072828B2 (en) 2003-04-23 2015-07-07 Valeritas, Inc. Hydraulically actuated pump for long duration medicament administration
US9125983B2 (en) 2003-04-23 2015-09-08 Valeritas, Inc. Hydraulically actuated pump for fluid administration
US9511187B2 (en) 2003-04-23 2016-12-06 Valeritas, Inc. Hydraulically actuated pump for fluid administration
US10525194B2 (en) 2003-04-23 2020-01-07 Valeritas, Inc. Hydraulically actuated pump for fluid administration
US11642456B2 (en) 2003-04-23 2023-05-09 Mannkind Corporation Hydraulically actuated pump for fluid administration
US9089636B2 (en) 2004-07-02 2015-07-28 Valeritas, Inc. Methods and devices for delivering GLP-1 and uses thereof
US8361053B2 (en) 2006-03-30 2013-01-29 Valeritas, Inc. Multi-cartridge fluid delivery device
US8821443B2 (en) 2006-03-30 2014-09-02 Valeritas, Inc. Multi-cartridge fluid delivery device
US9687599B2 (en) 2006-03-30 2017-06-27 Valeritas, Inc. Multi-cartridge fluid delivery device
US10493199B2 (en) 2006-03-30 2019-12-03 Valeritas, Inc. Multi-cartridge fluid delivery device

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WO2001012250A1 (en) 2001-02-22
EP1210136A1 (en) 2002-06-05
ATE316393T1 (en) 2006-02-15
DE19939023A1 (en) 2001-02-22
US6736795B2 (en) 2004-05-18
AU5669800A (en) 2001-03-13
DE50012131D1 (en) 2006-04-13
US20020111589A1 (en) 2002-08-15
JP4274725B2 (en) 2009-06-10
US20040143217A1 (en) 2004-07-22
JP2003507093A (en) 2003-02-25
ES2256018T3 (en) 2006-07-16

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